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Trial record 6 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3

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ClinicalTrials.gov Identifier: NCT02300558
Recruitment Status : Terminated
First Posted : November 25, 2014
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the effect of oral eleclazine on mean daytime QTcF interval after 24 weeks of treatment with elecalzine in participants with long QT syndrome Type 3. During the single-blind treatment period (24 weeks), participants will receive eleclazine and/or eleclazine placebo. Following the single-blind treatment period, participants who have not permanently discontinued study drug will be eligible, at the discretion of the investigator, to continue receiving eleclazine during an open-label extension (OLE) phase.

Condition or disease Intervention/treatment Phase
Long QT Syndrome Type 3 Drug: Eleclazine Drug: Eleclazine placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 3, Single-Blind Study to Evaluate the Effect of Eleclazine (GS-6615) on Shortening of the QT Interval, Safety, and Tolerability in Subjects With Long QT Syndrome Type 3
Actual Study Start Date : December 17, 2014
Actual Primary Completion Date : December 12, 2016
Actual Study Completion Date : February 15, 2017


Arm Intervention/treatment
Experimental: Eleclazine (Single-blind treatment phase)
Eleclazine and/or eleclazine placebo up to Week 24
Drug: Eleclazine
Tablets administered orally
Other Name: GS-6615

Drug: Eleclazine placebo
Tablets administered orally

Experimental: Open-label Extension Phase
Eligible participants will continue to receive open-label eleclazine until this drug is commercially available for the treatment of patients with LQT3, or until Gilead terminates development of eleclazine for the treatment of patients with LQT3, or the investigator deems it no longer in the participant's best interest.
Drug: Eleclazine
Tablets administered orally
Other Name: GS-6615




Primary Outcome Measures :
  1. Change From Baseline in Mean Daytime QT Interval in Lead V5 Corrected for Heart Rate Using the Fridericia Formula (QTcF) Interval to Week 24 (Based on Standard 12-lead ECG Data) [ Time Frame: Baseline; Week 24 ]
    • Baseline was the Day 1 value.
    • QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds.
    • AUC0-6 for QTcF was calculated using the trapezoidal rule, mean of triplicate values, and actual time (latest of triplicate times).
    • Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from dosing to the 6 hour postdose time point.


Secondary Outcome Measures :
  1. Change From Baseline in Mean Daytime QTcF Interval (AUC0-6/6) to Week 12 (Lead V5; Standard 12-lead ECG) [ Time Frame: Baseline; Week 12 ]
    • Baseline was the Day 1 value.
    • QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds.
    • AUC0-6 for QTcF was calculated using the trapezoidal rule, mean of triplicate values, and actual time (latest of triplicate times) .
    • Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from dosing to the 6 hour postdose time point.

  2. Change From Baseline in Mean Daily (Daytime and Nocturnal) QTcF Interval to Week 24 (Lead V5; Holter) [ Time Frame: Baseline; Week 24 ]
    • Baseline was the Day 1 value.
    • QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds.
    • Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from predose to 6 hours postdose. Mean nocturnal QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from midnight to 6:00 AM. Daily was computed as the average of daytime (AUC0-6/6) and nocturnal (AUC0-6/6), with both values required to compute the average.

  3. Change From Baseline in Mean Nocturnal QTcF Interval to Week 24 (Lead V5; Holter) [ Time Frame: Baseline; Week 24 ]
    • Baseline was the Day 1 value.
    • QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds.
    • Mean nocturnal QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from midnight to 6:00 AM.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Individuals with an established diagnosis of LQT3 (by genotype testing)
  • Mean (of triplicate) QTc interval ≥ 480 msec (or ≥ 460 msec, for individuals who are currently taking ranolazine or Class I antiarrhythmic drugs such as mexiletine) at 3 or more time points, determined by standard 12-lead ECG, at screening

Key Exclusion Criteria:

  • Known mutations associated with type 1 long QT syndrome (LQT1) or type 2 long QT syndrome (LQT2)
  • Known or suspected history of seizures or epilepsy
  • History of heart failure defined as New York Heart Association (NYHA) Class IV and/or known left ventricular ejection fraction (EF) ≤ 45%
  • Body mass index (BMI) ≥ 40 kg/m^2 at screening
  • Severe renal impairment at screening (defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2, using the 4 Variable Modification of Diet in Renal Disease (MDRD) equation, as determined by the study center)
  • Abnormal liver function tests at screening, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN), or total bilirubin > 1.5 x ULN
  • An aborted cardiac arrest (ACA), implantable cardioverter-defibrillator (ICD) implantation, syncopal episode, or appropriate ICD therapy within 3 months prior to screening
  • Any other condition or circumstance that in the opinion of the investigator would preclude compliance with the study protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300558


Locations
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United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
University of Rochester Medical Center
Rochester, New York, United States, 14642
Canada, Nova Scotia
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
France
L'institut Du Thorax Nantes
Nantes, France, 44093
Groupe Hospitalier Bichat Claude Bernard
Paris, France, 75877
CHU Réunion Sud
Saint-Pierre, France, 97410
Germany
LMU Klinikum der Universität München
München, Germany, 80336
Israel
Tel Aviv Sourasky Medical Center
Tel-Aviv, Israel
Italy
Fondazione Salvatore Maugeri IRCCS
Pavia, Italy, 27100
Netherlands
Academisch Medisch Centrum Amsterdam
Amsterdam, Netherlands, 1105 AZ
United Kingdom
Barts and The London School of Medicine and Dentistry
London, United Kingdom, EC1M 6BQ
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02300558     History of Changes
Other Study ID Numbers: GS-US-372-1234
2014-000042-30 ( EudraCT Number )
First Posted: November 25, 2014    Key Record Dates
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
Type 3 long QT syndrome (LQT3)
Long QT syndrome
Congenital long QT
Sudden cardiac death

Additional relevant MeSH terms:
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Long QT Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities